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聚麦芽糖铁复合物治疗和预防儿童缺铁性贫血的有效性:一项系统评价和荟萃分析。

Effectiveness of iron polymaltose complex in treatment and prevention of iron deficiency anemia in children: a systematic review and meta-analysis.

作者信息

Mohd Rosli Ritzzaleena Rosli, Norhayati Mohd Noor, Ismail Shaiful Bahari

机构信息

Department of Family Medicine, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.

出版信息

PeerJ. 2021 Jan 13;9:e10527. doi: 10.7717/peerj.10527. eCollection 2021.

Abstract

BACKGROUND

Iron deficiency anemia (IDA) is commonly treated with iron formulations. Despite the expanding acceptance of iron polymaltose complex (IPC) among clinicians, there is sparse and contradictory evidence regarding its efficacy in the management of IDA in children. This systematic review and meta-analysis aimed to assess the effectiveness of IPC in the treatment and prevention of IDA in children.

METHODS

We searched the Cochrane Central Register of Controlled Trials, MEDLINE and Epistemonikos for all randomized control trials (RCTs) comparing oral IPC with standard oral iron supplementation for the treatment or prevention of IDA in children. We independently screened the titles and abstracts of identified trials before the full text of relevant trials was evaluated for eligibility. We then independently extracted data on the methods, interventions, outcomes, and risk of bias from the included trials. A random-effects model was used to estimate the risk ratios and mean differences with 95% confidence intervals.

RESULTS

Eight trials comprising 493 randomized patients were included and analyzed using three comparison groups. The comparison group of which was used to evaluate IPC and ferrous sulphate (FS) for treatment of IDA showed that IPC is less effective in increasing Hb (MD -0.81, 95% CI -1.08 to -0.53; I = 48%,  < 0.001; six studies, 368 participants; high certainty of evidence), ferritin (MD -21.24, 95% CI -39.26 to -3.23, random-effects; I = 65%,  = 0.020; 3 studies, 183 participants; moderate certainty of evidence) and MCV levels (MD -3.20, 95% CI -5.35 to -1.05;  = 0.003; one study, 103 participants; low certainty of evidence). There was no difference in the occurrence of side effects between IPC and FS group (MD 0.78, 95% CI 0.47 to 1.31; I = 4%,  = 0.35; three studies, 274 participants; high certainty of evidence).

CONCLUSIONS

There was moderate to high certainty evidence that FS is superior to IPC with a clinically meaningful difference in improving the Hb and ferritin levels in the treatment of IDA in children. There was no difference in the occurrence of gastrointestinal side effects with high certainty evidence between the IPC and FS groups. The body of evidence did not allow a clear conclusion regarding the effectiveness of IPC with iron gluconate and iron bisglycinate in the prevention and treatment of IDA. The certainty of evidence was low. Adequately powered and high-quality trials with large sample sizes that assess both hematological and clinical outcomes are required.

摘要

背景

缺铁性贫血(IDA)通常采用铁制剂进行治疗。尽管铁聚麦芽糖复合物(IPC)在临床医生中越来越被广泛接受,但关于其在儿童IDA管理中的疗效证据却稀少且相互矛盾。本系统评价和荟萃分析旨在评估IPC在治疗和预防儿童IDA方面的有效性。

方法

我们检索了Cochrane对照试验中央注册库、MEDLINE和Epistemonikos,以查找所有比较口服IPC与标准口服铁补充剂治疗或预防儿童IDA的随机对照试验(RCT)。在对相关试验的全文进行资格评估之前,我们独立筛选了已识别试验的标题和摘要。然后,我们独立从纳入的试验中提取有关方法、干预措施、结果和偏倚风险的数据。采用随机效应模型来估计风险比和平均差,并给出95%置信区间。

结果

纳入八项试验,共493例随机分组患者,并分为三个比较组进行分析。用于评估IPC和硫酸亚铁(FS)治疗IDA的比较组显示,IPC在提高血红蛋白(MD -0.81,95% CI -1.08至-0.53;I² = 48%,P < 0.001;六项研究,368名参与者;证据确定性高)、铁蛋白(MD -21.24,95% CI -39.26至-3.23,随机效应;I² = 65%,P = 0.020;三项研究,183名参与者;证据确定性中等)和平均红细胞体积水平(MD -3.20,95% CI -5.35至-1.05;P = 0.003;一项研究,103名参与者;证据确定性低)方面效果较差。IPC组和FS组之间副作用的发生率没有差异(MD 0.78,95% CI 0.47至1.31;I² =  4%,P = 0.35;三项研究,274名参与者;证据确定性高)。

结论

有中等到高度确定性的证据表明,在治疗儿童IDA时,FS在提高血红蛋白和铁蛋白水平方面优于IPC,且具有临床意义上的差异。IPC组和FS组之间胃肠道副作用发生率在高确定性证据下没有差异。现有证据无法就IPC与葡萄糖酸铁和甘氨酸亚铁在预防和治疗IDA方面的有效性得出明确结论。证据的确定性较低。需要进行有足够效力和大样本量的高质量试验,以评估血液学和临床结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d94/7811280/6190c9065eab/peerj-09-10527-g001.jpg

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